Phase I/II study with SARS-CoV-2 virus vaccine against COVID-19 [COVID-19] [UPH]
Research type
Research Study
Full title
A PHASE I/II RANDOMIZED, TWO PARTS, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF AN INACTIVATED, ADJUVANTED SARS-COV-2 VIRUS VACCINE CANDIDATE (VLA2001), AGAINST COVID-19 IN HEALTHY SUBJECTS
IRAS ID
289098
Contact name
Adam Finn
Contact email
Sponsor organisation
Valneva Austria GmbH
Eudract number
2020-005062-33
ISRCTN Number
ISRCTN82411169
Duration of Study in the UK
0 years, 8 months, 12 days
Research summary
Summary of Research
This first in human (FIH) study is initiated in response to the current COVID-19 pandemic. This study will be conducted 4 sites in the UK only, planning to recruit 150 healthy volunteers between the ages of 18 and 55 years.\n\nThe study will be conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). In Part A participants will be recruited to each of the 3 dose groups and will be divided in an open-label, dose-escalation period and a double-blinded, randomised recruitment part of the study. The first 5 participants in each dose group will receive VLA2001 open label in a dose- and time-escalating manner (sentinel group); the remaining 135 participants will be recruited in the randomised part of Part A. Randomisation will take place via IWRS. Dose escalation will take part at a single site to ensure complete oversight of the safety aspect of the study. Each of the 15 sentinel subjects will be observed on-site for at least 60 minutes following vaccination. All participants will receive 2 vaccinations, on day 1 and day 22. A Data Safety and Monitoring Board (DSMB) will review the accrued safety data after the sentinel subjects of the high dose group have passed their 3-days post vaccination time point before randomization of subjects across all sites will be initiated. Participants will provide several samples at intervals, such as baseline serology, blood samples for safety labs, immunogenicity and PBMC isolation, as well as saliva samples (which participants will also collect at home). Following vaccination, electronic dairies will be completed for 7 days to capture solicited injections site and systemic reactions; unsolicited AEs will be captured until day 208. In Part B, subjects will be followed up on Day 106 and Day 208/Month 7, 6 months after the second vaccination.Summary of Results
The Phase 1/2 study recruited a total of 153 participants aged 18 years and older across four sites located in the UK. Based on the results of this study, the high dose level was selected for further clinical development. Additionally, 77 of the 153 participants have received a booster dose (high dose) seven to eight months after completion of their primary immunization. This third dose of VLA2001 elicited an excellent immune response, with similar antibody levels observed across participants independently of which dose group they were allocated to for the primary immunization (i.e.: initially vaccinated with a low, medium or high dose).The clinical study report concluded –
• VLA2001 was generally safe and well tolerated across all dose groups tested with no safety concerns up to 6 months post primary vaccination (2 doses).
• The high dose group was selected for Phase 3 development stage based on a comparable safety profile and superior immunogenicity results compared to the low and medium dose group in VLA2001-201.
• The Booster dose of VLA2001 (third dose), administered approximately 8 months after the second dose of primary vaccination, was safe and well tolerated. A third dose of VLA2001 induced a booster response independently of the participants priming with a 2-dose schedule of low, medium, or high dose VLA2001.Valneva received a Conditional Marketing Authorization in the UK in April 2022 for primary immunization in adults aged 18 to 50 years as well as Emergency Use Authorization in Bahrain in March 2022, and in the United Arab Emirates in May 2022, in each case for adults above 18 years of age.
REC name
London - Brent Research Ethics Committee
REC reference
20/HRA/5205
Date of REC Opinion
23 Nov 2020
REC opinion
Favourable Opinion